Europe
assessing if weight affects 'morning after pill' success
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[January 24, 2014]
LONDON (Reuters)
— European regulators said on Friday they would assess
whether emergency contraceptives, known as the "morning after pill"
worked as effectively in women weighing more than 75 kilograms (165
pounds), and
whether the warning labels should be changed.
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The review was requested by the Swedish medicines
regulatory agency, which decided in November to amend the product
information for Norlevo, which contains levonorgestrel, the European
Medicines Agency said.
The labeling was changed to say that in clinical trials,
contraceptive efficacy was reduced in women weighing 75 kg (165
pounds) or more,
and levonorgestrel was not effective in women who weighed more than
80 kg (176 pounds).
Emergency contraceptives, which contain levonorgestrel or uliprista
acetate in the European Union, act by blocking or delaying
ovulation.
The emergency contraceptives being reviewed include medicines that
contain levonorgestrel, such as Norlevo, Levonelle/Postinor and
Levodonna, the EMA said.
It also includes a centrally authorized medicine, ellaOne, which
contains ulipristal acetate and was granted a marketing
authorization in Europe in 2009.
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The United States is also reviewing the effect of weight on the
efficacy of emergency contraception.
(Reporting by Paul Sandle)
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